Clinical Trial on Remote Ischemic Preconditioning and Cerebral Small Vessel Disease
NCT ID: NCT01658306
Last Updated: 2014-11-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
30 participants
INTERVENTIONAL
2012-07-31
2014-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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remote ischemic preconditioning
Receiving remote ischemic preconditioning (RIPC) treatment with pressure set at 200 mmHg.
remote ischemic preconditioning
RIPC consists of five 5-min cycles of right upper arm ischemia/reperfusion, induced by an automated cuff-inflator placed on the right upper arm which is inflated to 200 mmHg for 5mins followed by deflating the cuff for 5mins, each patient in the RIPC group will have the treatment twice a day for two weeks.
placebo remote ischemic preconditioning
Receiving sham RIPC treatment with pressure set at 50 mmHg
sham remote ischemic preconditioning
Sham RIPC consists of five 5-min cycles of right upper arm ischemia/reperfusion, induced by an automated cuff-inflator placed on the right upper arm which is inflated to 50 mmHg for 5mins followed by deflating the cuff for 5mins, each patient in the placebo RIPC group will have the treatment twice a day for two weeks.
Interventions
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remote ischemic preconditioning
RIPC consists of five 5-min cycles of right upper arm ischemia/reperfusion, induced by an automated cuff-inflator placed on the right upper arm which is inflated to 200 mmHg for 5mins followed by deflating the cuff for 5mins, each patient in the RIPC group will have the treatment twice a day for two weeks.
sham remote ischemic preconditioning
Sham RIPC consists of five 5-min cycles of right upper arm ischemia/reperfusion, induced by an automated cuff-inflator placed on the right upper arm which is inflated to 50 mmHg for 5mins followed by deflating the cuff for 5mins, each patient in the placebo RIPC group will have the treatment twice a day for two weeks.
Eligibility Criteria
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Inclusion Criteria
2. Ischemic cerebrovascular event onset, if any, must be within 6 months;
3. TCD and carotid ultrasound exclude vascular narrow that can cause hemodynamic changes (usually \>50% narrow lumen);
4. MRI confirmed the presence of lacunar infarction and / or generalized white matter lesions;
5. Written consent was obtained from the subject.
Exclusion Criteria
2. Significant bleeding from other parts of the body;
3. History of atrial fibrillation;
4. History of myocardial infarction within six months;
5. Moyamoya disease or vasculitis;
6. Hereditary small vessel disorders, such as CADASIL, FABRY, and mitochondrial encephalo-myopathy;
7. Significant bleeding-coagulation dysfunction;
8. Abnormal blood pressure, glucose and/or lipids after restrict treatment regimen;
9. Severe liver/kidney disease, cancer or critical illness of internal medicine and surgery.
40 Years
80 Years
ALL
No
Sponsors
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Peking University First Hospital
OTHER
Capital Medical University
OTHER
Responsible Party
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Ji Xunming
Professor of Neurosurgery, Vice-President of Xuan Wu Hospital, Capital Medical University
Principal Investigators
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Xunming Ji, M.D., Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Xuan Wu Hospital of Capital Medical University
Locations
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Xuan Wu Hospital
Beijing, , China
Countries
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References
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Wang Y, Meng R, Song H, Liu G, Hua Y, Cui D, Zheng L, Feng W, Liebeskind DS, Fisher M, Ji X. Remote Ischemic Conditioning May Improve Outcomes of Patients With Cerebral Small-Vessel Disease. Stroke. 2017 Nov;48(11):3064-3072. doi: 10.1161/STROKEAHA.117.017691. Epub 2017 Oct 17.
Mi T, Yu F, Ji X, Sun Y, Qu D. The Interventional Effect of Remote Ischemic Preconditioning on Cerebral Small Vessel Disease: A Pilot Randomized Clinical Trial. Eur Neurol. 2016;76(1-2):28-34. doi: 10.1159/000447536. Epub 2016 Jun 29.
Other Identifiers
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D111107003111008
Identifier Type: -
Identifier Source: org_study_id